Flexible vacuum grabber for holding lesions

ABSTRACT

A grabbing device includes a transparent flexible cup that can be placed adjacent to a selected region of an inner surface of a body cavity. The flexible cup is visually put in place by the surgeon, and a vacuum is applied to draw a selected amount of tissue into the flexible cup, so that it may, e.g., be excised. The device may also retrieve the tissue excised from the body cavity.

This application is a continuation of U.S. patent application Ser. No.10/004,939, filed Dec. 3, 2001 (“the '939 application”), now U.S. Pat.No. 6,648,897, which is a divisional of U.S. patent application Ser. No.09/456,835 filed on Dec. 7, 1999 (“the '835 application”), now U.S. Pat.No. 6,383,198. The entire disclosures of the '939 application and the'835 application are hereby expressly incorporated herein by reference.

The present invention is directed to a vacuum grabbing device used togrip and maneuver a suspect area within a body cavity. Morespecifically, the invention is directed to a vacuum device for grippinga suspect lesion found in a body cavity and positioning it so that itcan be excised and withdrawn from the body cavity.

DESCRIPTION OF RELATED ART

Endoluminal procedures have become very common, and millions of theseprocedures are performed each year in hospitals around the world. Anendoluminal procedure is a medical procedure that takes place within oneof the many tube-like cavities, also called lumens, that are presentwithin the human body. Endoluminal procedures may take place invascular, gastrointestinal, or air exchange lumens, and may involvedisease diagnosis as well as treatment of certain diseases.

Endoluminal procedures are often performed by using a device known asthe endoscope. An endoscope is a tube, either rigid or flexible, whichis introduced through an opening into a lumen in the human body. In thecase of the gastrointestinal passage, the endoscope can be insertedeither through the mouth or through the rectum. The endoscope may beused simply to hold the lumen open for examination, but often alsocarries light and vision systems, so that the operator can see withinthe lumen. The endoscope also often includes a working channel, usuallyformed within the body of the endoscope, so that the surgeon can insertand withdraw other instruments and diagnostic or treatment devicesthrough the endoscope, to easily reach the position within the lumenbeing observed by the endoscope.

One important use of the endoscope is to allow the surgeon to view thepatient internally, even when the portion of the patient's body cavityto be viewed is not in a direct line of sight from outside of the body.For this purpose, endoscopes typically contain a lens coupled to avisual display device by fiber optic cables, so that the body cavity infront of the endoscope can be remotely viewed on a TV screen. Thiscommon procedure is known as laparoscopy, and involves inserting theendoscope into the patient through a small incision made by the doctor,or alternatively through natural body openings like the colon or theesophagus.

Another common application of endoluminal procedures is the removal oftumors or of suspected tumor lesions inside the body cavity. In aconventional retrieval operation, an endoscope is inserted into aninternal cavity of the patient, such as the colon. The endoscope is usedto identify and locate the suspect region within the internal cavity, sothat the suspect area can be removed. Conventionally, graspers have beenused to grip tissue and draw it into a device for excision.

Staples are then used to close the opening so that it may heal moreeffectively. The graspers are manipulated from outside the body and thecutting and stapling operations also are controlled and manipulated fromoutside the patient's body. Tiny grippers are generally used to graspthe lesion, but their positioning and the amount of tissue they grip isinaccurate, and often too much or too little tissue is removed.

The use of endoscopes typically reduces the size of the incision neededto perform a surgical procedure, thus allowing the patient to recoverfaster. In some cases no incision is necessary, since the endoscope isintroduced through an existing body opening. Various types of tools suchas cutters, vacuum suction devices, and other tools can be insertedthrough a working channel of an endoscope, and can be operated by thesurgeon as they are guided to the appropriate section of the body cavitythrough the working channel of the endoscope. The tools are manuallysteered by the surgeon from the proximal end of the endoscope, i.e., theend remaining outside of the body. Other devices such as fiber opticcables used to carry illumination and images are generally part of theendoscope itself, and do not intrude in the working channel of theendoscope.

One specific tool that can be used in conjunction with the endoscope isthe full thickness resectioning device, or FTRD. The FTRD is inserted inthe body cavity, and has a working channel through which an endoscopeand other tools can be inserted. The endoscope is advanced under visualobservation until a desired location is visible. The FTRD is then pushedalong the endoscope to the proper location within the body cavity, atwhich point other devices may be inserted through the working channel ofthe FTRD to the endoscope's location. The tissue to be removed is drawninto a chamber of the FTRD and then cut away from the surroundinghealthy tissue while ensuring that no part of the tissue to be removedremains within the body cavity. The FTRD simultaneously staples togetherthe severed sides of the healthy tissue to close up the wound andpromote healing. Alternatively, the tissue may be stapled around thetissue to be removed before cutting. This procedure may eliminate theneed for surgery and expedites recovery. However, one difficulty ofusing the FTRD to remove a tumor is that it may be difficult to bringthe entire tumor into the chamber, and to ensure that no part of thetumor has been left in the body cavity.

When a biopsy or a resectioning is performed either using an FTRD oranother biopsy device, the device is required to grip the suspect tissuebefore it is cut away. When the FTRD is used, the wound left by theremoval of a large suspect section of tissue is closed by staplingtogether the surrounding healthy tissue so it may heal more easily.However, when a biopsy is conducted, the sample taken is generally muchsmaller, and therefore it is not necessary to use staples to close thewound. In both cases, it is important to grip the proper amount oftissue, so that the suspect portion of body cavity tissue is accuratelypulled away from the wall of the body cavity lumen.

SUMMARY OF THE INVENTION

The present invention is directed to a vacuum grabber device thatsubstantially obviates one or more of the problems due to thelimitations and disadvantages of the related art, and can be used tomore easily and accurately remove suspect areas in body cavities.Additional features and advantages of the invention will be set forth inthe description which follows, and in part will be apparent from thedescription, or may be learned by practice of the invention. Otheradvantages of the invention will be realized and obtained by theapparatus and method particularly pointed out in the written descriptionand claims hereof, as well as the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the invention, as embodied and broadly described, the invention is avacuum grabber device adapted for use with an insertion device insertedin the body cavity, comprising a vacuum line slidable within a workingchannel of the insertion device and having a distal end insertable inthe insertion device, a substantially transparent flexible cup attachedto the distal end of the vacuum line foldable to fit within the workingchannel and deployable to a configuration substantially funnel shaped,means for applying a vacuum to the flexible cup, and means forpositioning the deployed flexible cup within the body cavity such thatthe flexible cup can hold a selected inner portion of the body cavity byvacuum, and can be at least partially withdrawn into the insertiondevice while holding the selected inner portion. A vision device is usedto view the selected inner portion of the body cavity through theflexible cup.

In another embodiment, the invention is a method for removing a selectedportion of tissue from a surface of a body cavity, having the steps ofinserting into the body cavity an insertion device, advancing throughthe insertion device a substantially transparent flexible cup in afolded configuration within the insertion device, deploying from theinsertion device the flexible cup in a substantially funnel shapedconfiguration, and visually positioning the deployed flexible cupadjacent to the selected portion of tissue by observing the selectedportion of tissue through the flexible cup. The steps of the method alsoinclude applying a vacuum pressure through the flexible cup to draw theselected portion of tissue into the flexible cup, and at least partiallywithdrawing the flexible cup proximally into the insertion device todraw the selected portion of tissue into a desired position relative tothe insertion device.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the invention and are incorporated in an constituentpart of this specification, illustrate several embodiments of theinvention and together with a description serve to explain the presentinvention. In the drawings:

FIG. 1 is a diagram showing a cut-away view of the vacuum grabber deviceaccording to one embodiment of the invention, deployed from an insertiondevice located within a body cavity;

FIG. 2 is a diagram showing a cut-away view of the vacuum grabber deviceaccording to an embodiment of the present invention, in a foldedconfiguration within the insertion device; and

FIG. 3 is a diagram showing the flexible cup of the vacuum grabberdevice shown in FIG. 2, in a deployed configuration.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a device and method to ensure that aselected inner portion of a body cavity is gripped, so that a suspectarea possibly containing a tumor as well as a small surrounding area ofhealthy tissue may be removed. The additional amount of healthy tissuebeing removed is necessary to provide a safety margin portion of tissue,to ensure that all of the suspect area has been cut away from the bodycavity. The invention also ensures that the entire tissue sample thathas been cut is actually removed from the body cavity before theendoscope and associated tools are removed. The invention prevents thecut tissue from falling out of the device and being left within the bodycavity, so that further study of the removed tissue to perform adiagnosis is possible. The invention protects the cut tissue from thesurrounding area while withdrawing it from the body cavity, so that thesample is not contaminated by extraneous materials on the way out of thebody cavity. In addition, the invention limits the amount of healthytissue surrounding the suspect area that is damaged when the suspectarea is removed from the body cavity.

FIG. 1 shows a diagram of an embodiment according to the invention, usedin conjunction with a FTRD to remove a suspect area from a body cavity.FTRD 10 is inserted within a body cavity 20 either through an incisionmade by the surgeon or through a natural opening of the cavity. Bodycavity 20 is roughly tubular in shape, and has an inner surface 22 thatincludes a suspect area 24. The suspect area 24 may be either a lesionthat has to be removed and analyzed to determine if it is cancerous, ora growth such as a polyp that has to be removed, or from which a biopsymust be taken. The vacuum grabber device 30 is inserted inside a workingchannel 36 formed in the center of the FTRD 10, and includes a vacuumline 32 and a flexible cup 34 attached to the vacuum line 32.

The vacuum grabber device 30 is adapted to be inserted in the FTRD 10,so that both components can be introduced within the patient's bodycavity 20. The distal end of FTRD 10 is placed in position near thesuspected lesion 24 located on inner wall 22 of the body cavity 20, andthe vacuum grabber device 30 can thus also reach the suspected lesion24. When vacuum grabber device 30 is inserted in the working channel ofFTRD 10, the flexible cup portion 34 is in the folded configuration, sothat it can more easily travel through working channel 36. FIG. 2 showsthis configuration. Once FTRD 10 is positioned within the body cavity 20near the suspect region 24, head assembly 38 of the FTRD 10 is opened,for example by pushing on control wire 40 which connects the headassembly 38 to an area outside of the patient's body. Once head assembly38 is opened, vacuum grabber device 30 is pushed outside of FTRD 10through an opening between the main body of FTRD 10 and the headassembly 38.

Although the present embodiment of the invention is described inconjunction with a FTRD, other insertion devices capable of excising aportion of tissue within a body cavity can also be used. The presentinvention is thus generally usable to capture a suspect portion of theinner surface of a body cavity so that treatment, observations orremoval to the suspect portion of tissue may be performed.

In another embodiment according to the invention, vacuum grabber device30 could be inserted into the patient's body cavity 20 by means of aninsertion device other than an FTRD that can shield the vacuum line 32and the flexible cup 34.

Once the insertion device reaches the suspect area of interest, anopening could be made in the insertion device to eject the vacuumgrabber device 30. For example, the insertion device could be similar tothe FTRD, but without the ability to cut and staple the tissue of thebody cavity 20. As described above, the cutting and stapling functionscould be performed by additional tools inside or adjacent to theinsertion device.

As shown in FIGS. 1 and 3, vacuum grabber device 30 is pushed outside ofthe opening made between head assembly 38 and the main body of FTRD 10,at which point the folded flexible cup 34 automatically deploys into asubstantially funnel shaped configuration.

In a preferred embodiment according to the invention shown in FIG. 3,the flexible cup in the deployed configuration has a substantiallyfunnel shape, with a small opening 31 connected to the vacuum line 32,and a larger opening 46 adapted to be placed over the suspect region 24that requires treatment. The flexible cup can have openings that are notround, as long as it can be connected to the source of vacuum, and thelarge opening can cover the desired portion of tissue.

After exiting the working channel 36 of FTRD 10, the flexible cup 34opens to its deployed configuration automatically, due to the forceexerted by resilient elements that make up the structure of flexible cup34. For example, a resilient ring-like structure 42 can be disposed nearthe large opening 46, so that once it is no longer constrained, flexiblecup 34 will open to its funnel configuration. In addition, or instead ofresilient ring 42, several resilient ribs 44 can be located on the sidesof flexible cup 34 to force it in the deployed configuration once its nolonger constrained within working channel 36. The resilient elements canbe embedded in a transparent membrane 40 forming the flexible cup, orcan be placed inside or outside of membrane 40. Other configurations ofresilient elements 42 and 44 could be used, such as spiralconfigurations, multiple rings, or any other known configurations thatwill open flexible cup 34 to its proper shape.

The vacuum grabber device 30 can be moved axially along the inside ofbody cavity 20 by simply pushing or pulling on the vacuum line 32. Inaddition, in one embodiment according to the invention, flexible cup 34is placed at an angle from the center line of vacuum line 32, so thatrotating vacuum line 32 will cause large opening 46 of flexible cup 34to sweep in a generally circumferential direction along the innersurface 22 of body cavity 20. This configuration allows large opening 46to be placed over a selected portion of the body cavity.

In one preferred embodiment according to the invention, the flexible cup34 is made of a flexible polymer that is clear, for example, aplasticized silicon material. Other materials could be used that aretransparent and substantially air tight, so that a vacuum can be appliedand held by the flexible cup. The materials preferably can insulate thesuspect lesion or other tissue that was removed from the surroundingbody cavity, so that it will not be contaminated by extraneous materialswhen it is withdrawn from the body. The flexible cup must besufficiently transparent so that the tissue in question can be seenthrough the flexible cup. For example, an endoscope could be used tolook at the tissue through membrane 40.

In yet another embodiment according to the invention, a mesh 50 or othertype of screen can be located in the vacuum line 32, or near the smallopening of flexible cup 34. This screen is designed to prevent portionsof the tissue that was removed from traveling down the vacuum line, andcan also be used to form a holding area for the tissue, so that it willbe protected from contamination by vacuum line 32 and by the membrane 40of flexible cup 34.

The operation of vacuum grabber device 30 will now be explained withreference to FIGS. 1 through 3. FTRD 10 or another type of insertiondevice is inserted in body cavity 20 and is navigated by the surgeon toa location near suspect lesion 24, located on inner surface 22 of thebody cavity 20. At this point, vacuum grabber device 30 is insideworking channel 36 of FTRD 10, and flexible cup 34 is in the foldedconfiguration shown in FIG. 2. When FTRD 10 is in place, head assembly38 is opened, and flexible cup portion 34 is ejected outside of FTRD 10.

As explained above, flexible cup 34 opens in its funnel configurationonce no longer constrained in working channel 36. The surgeon can lookfor suspect lesion 24 through the endoscope 11 which is also insertedthrough the working channel of FTRD 10, and can position flexible cup 34over the suspect lesion by rotating, pulling and pushing vacuum line 32.By looking with the endoscope 11 through transparent membrane 40 offlexible cup 34, the surgeon can position the funnel-like flexible cupover the suspect lesion 24, and can start applying a vacuum by operatingmeans, such as vacuum pump 60, which can provide both an adjustablevacuum and positive pressure in vacuum line 32.

While looking through transparent membrane 40 of flexible cup 34, thesurgeon can vary the amount of vacuum and positive pressure applied tothe flexible cup 34, so that the selected inner portion of the bodycavity containing the suspect lesion 24 as well as a safety marginportion 26 of healthy tissue surrounding the suspect lesion 24 isgripped and contained within flexible cup 34. In a preferred embodiment,the safety margin portion 26 can extend beyond lesion 24 by about 3 mmto 6 mm.

When the surgeon is satisfied that the selected inner portion of bodycavity is firmly held by vacuum within flexible cup 34, the vacuumgrabber device 30 can be partially withdrawn inside the FTRD 10 to pullthe selected inner portion of body cavity into a desired operatingposition relative to the FTRD 10, inside the chamber 44 formed by theopen head assembly 38.

The surgeon at that point can operate cutting device 56 that is part ofthe FTRD 10, to separate the selected inner portion of the body cavityfrom the rest of inner surface 22. For example, cutting device 56 can bean extendable and movable blade. A stapling portion 58 of FTRD 10 can beused at that point to close the wound left by the removed portion of thebody cavity, so that healing will be promoted. The specificconfiguration of cutting device 56 and stapling portion 58 can vary, aslong as a portion of the body cavity drawn inside FTRD 10 is cut and thesevered sides of the remaining healthy tissue are stapled together.

The selected inner portion of body cavity containing suspect lesion 24as well as a margin of safety portion 26 of healthy tissue is thus heldby vacuum within flexible cup 34, and after cutting is withdrawn fromthe body of the patient while being protected from contamination bymembrane 40 of flexible cup 34. A pathology study of suspect lesion 24can then be carried out without the concern that the results may beaffected by possible contamination of the sample.

According to one embodiment of the invention, the selected inner portionof body cavity that was removed can be held near the flexible cup 34 bya screen 50 acting as a sample catcher. Alternatively, the selectedinner portion can be drawn by vacuum all the way down vacuum line 32,and can be collected outside of the body at the proximal opening ofvacuum line 32.

In one embodiment, FTRD 10 can be inserted into the patient and cancarry an endoscope in a working channel of the FTRD. Alternatively, theFTRD could be inserted separately from the endoscope, in the samecavity. The important consideration in positioning the endoscope is thatthe surgeon must be able to see the flexible cup 34 and the suspectlesion area 24, so that the transparent flexible cup 34 can be correctlyplaced over the lesion area 24, and the selected inner portion of thebody cavity can be drawn within flexible cup 34.

In yet another embodiment according to the invention, flexible cup 34can be provided in various sizes, so that the appropriate cup can beapplied to different size lesions to ensure that the entire lesion plusa safety margin of healthy tissue can be drawn inside the flexible cup34. In addition, for cases where the lesion 24 has a very irregularshape, specially designed flexible cups could be used, either havingvery high flexibility or having specific shapes of the large opening 46to accommodate the irregularly shaped lesion. In the latter case,flexible cup 34 should have dimensions commensurate with the largestdimension of the lesion, such as the lesion length or diameter. Anincreased vacuum may also be necessary to firmly hold a lesion having anirregular shape within flexible cup 34.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the structure andmethodology of the present invention, without departing from the spiritor scope of the invention. Thus, it is intended that the presentinvention covers the modifications and variations of this inventionprovided they come within the scope of the appended claims and theirequivalents.

1. A method for removing a selected portion of tissue from a surface of a body cavity, comprising the steps of: inserting into the body cavity an insertion device; advancing a substantially transparent flexible cup through a lumen of the insertion device in a folded insertion configuration; advancing the flexible cup distally from the lumen of the insertion device, wherein the flexible cup deploys to an operative configuration in which the flexible cup is substantially funnel shaped as it exits the lumen; visually positioning the flexible cup adjacent to the selected portion of tissue by observing the selected portion of tissue at least partially through the flexible cup; applying a vacuum pressure to an interior of the flexible cup to draw the selected portion of tissue thereinto; severing the selected portion of the tissue from surrounding tissue; withdrawing the flexible cup into the lumen while maintaining vacuum pressure within the flexible cup to retain the severed tissue within the flexible cup; and maintaining the selected portion of tissue within the flexible cup during withdrawal of the flexible cup from the body.
 2. The method according to claim 1, further comprising the step of withdrawing the flexible cup proximally relative to the insertion device to alter a position of the selected portion of tissue relative to the insertion device.
 3. The method according to claim 1, wherein the insertion device includes an endoscope, and wherein the visually positioning step includes the sub steps of: positioning the endoscope to view the selected portion of tissue; and maneuvering the transparent flexible cup relative to the endoscope to observe the selected portion of tissue through the flexible cup so that the selected portion of tissue and a safety margin area therearound are substantially centered within the transparent flexible cup.
 4. The method according to claim 1, farther comprising the step of: fastening portions of tissue around a periphery of the selected portion of tissue.
 5. A method for removing a selected portion of tissue from a surface of a body cavity, comprising the steps of: inserting into the body cavity an insertion device; advancing a substantially transparent flexible cup through a lumen of the insertion device in a folded insertion configuration; advancing the flexible cup distally from the lumen of the insertion device, wherein the flexible cup deploys to an operative configuration in which the flexible cup is substantially funnel shaped as it exits the lumen; visually positioning the flexible cup adjacent to the selected portion of tissue by observing the selected portion of tissue at least partially through the flexible cup; applying a vacuum pressure to an interior of the flexible cup to draw the selected portion of tissue thereinto; fastening portions of tissue around a periphery of the selected portion of tissue; severing the selected portion of tissue from the surrounding tissue, wherein the portions of tissue around the periphery of the selected portion of tissue are fastened together by stapling; withdrawing the flexible cup into the lumen while maintaining vacuum pressure within the flexible cup to retain the severed tissue within the flexible cup; and maintaining the selected portion of tissue within the flexible cup during withdrawal of the flexible cup from the body. 